Real World Evidence Scientific Working Group

  • Session on Utility of Real-World Evidence in Medical Product Development and Life Cycle Management (ASA BIOP RISW 2018)
  • Emerging Opportunities for Utilizing Real-World Evidence to Impact Drug Development and Regulatory Decision-Making (Topic-contributed JSM 2019)
  • Recent Statistical Developments in Considering Real World Evidence for Regulatory Decision Making (2019 JSM)
  • Session on Challenges and Opportunities in the Use of Real-World Evidence in Regulatory Decision-Marking of Medical Products: An ASA BIOP RWE SWG Progress (ASA BIOP RISW 2019)
  • Invited session on Translating Real-World Data into Real-World Evidence for Regulatory Decisions and Medical Practice: Opportunities and Challenges (JSM 2020)
  • Session on Addressing Challenges and Opportunities in the Use of Real-World Evidence in Regulatory Decision-Marking of Medical Products: ASA BIOP RWE SWG Interim Progress report (ASA BIOP RISW 2020)
  • Session on Key Steps in Deriving Real-World Evidence from Analysis of Real-World Data –Topic-Contributed Papers (2021 JSM)
  • Session on Addressing Key Issues to Promote the Uptake of Using RWE/D for Regulatory Decisions – Topic-Contributed Papers (2022 JSM)
  • Sensitivity analysis for the identifiability assumptions (RISW 2023)
  • The current landscape in regulatory use of real-world evidence studies (RISW 2024)
  • Practical Considerations for Transforming RWD into RWE (short course; RISW 2024)
  • Innovative Approaches to Address Challenges in Externally Controlled Trial Designs (RISW, 2025)
  • Statistical Design and Analysis of Hybrid Controlled Trials with Real-World External Controls (short course; RISW, 2025)
  •  Integrative approaches to treatment evaluation leveraging randomized clinical trials and real-world data; Innovations at the Interface of Statistics, AI, and Real-World Evidence (JSM 2025)
  • Decentralized Clinical Trials in the Era of Real-World Evidence Generation (2025 MBSW)
  • Estimands in Real-World Studies (2025 PHUSE)
  • Account for Unmeasured Confounding via Negative Control for Robust Real-World Evidence Generation (2026 SCOPE)